Identity
- Trade Name
- LiDCO Module EUDAMEDLiDCO FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- LiDCO Module EUDAMEDFDA UDI
- Model / Reference
- 95059 EUDAMEDFDA UDI
- Description
- LiDCO Module FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997001823 EUDAMEDFDA UDI
- Basic UDI-DI
- 084399700000Z7T4C01V000NM EUDAMED
- Direct Marketing DI
- 00843997017190 EUDAMED
- 510(k) Number
- K163334 FDA UDI
- FDA Product Code
- DXG FDA UDI
- EMDN Code
- Z12050702 POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1435 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
LiDCO Module by Masimo Corporation — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 084399700000Z7T4C01V000NM | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Masimo Corporation
- EUDAMED SRN
- US-MF-000010641
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED f83d165c-8a28-4204-a2eb-eb42f8660209 61 fields · synced Jun 19, 2026
- FDA UDI ded359ab-df96-4cf1-9828-f56439119200 36 fields · synced May 30, 2026